Infusion time for Roche’s OCREVUS reduced by 1.5 hours

Based on results from the ENSEMBLE PLUS study which showed comparable severity and occurrence of infusion-related reactions for a two-hour OCREVUS (ocrelizumab) infusion time compared with the currently approved 3.5 hour infusion time, the FDA has now approved Roche’s supplemental Biologics License Application and the EMA has validated the application for the shorter infusion time, dosed twice yearly for relapsing or primary progressive multiple sclerosis. OCREVUS is the first and only therapy approved for RMS (including relapsing-remitting MS and active, or relapsing, secondary progressive MS, in addition to clinically isolated syndrome in the U.S.) and primary progressive MS. It is a monoclonal antibody that targets CD20-positive B cells, an immune cell believed to be partly responsible for myelin and axonal damage, which can lead to disability in MS patients. The product is approved in the EU, Australia and Switzerland plus 90 further countries across Eastern Europe, North America, South America and the Middle East.
Roche’s Chief Medical Officer and Head of Global Product Development, Levi Garraway, said: “With more than 150,000 people treated with OCREVUS, the twice-yearly dosing schedule has benefited many MS patients and their physicians, as indicated by more than 90% of patients continuing with treatment through one year. We hope a shorter infusion time will further improve the experience for people living with MS while also increasing capacity in healthcare systems.”